Device, systems, methods and tools for continuous glucose monitoring

Abstract

The present invention includes methods and apparatus for continuous glucose monitoring of a patient. In one aspect a glucose monitor includes a plurality of substantially cylindrical tissue piercing elements adapted to pierce the stratum corneum and enter the epidermis, allowing for the diffusion of glucose from the interstitial fluid into the glucose monitors described herein. In another aspect of the invention, a glucose monitor includes a deformed substrate layer defining a plurality of tissue piercing elements.

Description

CROSS-REFERENCE[0001]This patent application is related to co-assigned pending patent applications Ser. No. 11 / 277,731 filed Mar. 28, 2006, and Ser. No. 11 / 468,732 filed Aug. 30, 2006, both of which are incorporated by reference herein in their entirety.INCORPORATION BY REFERENCE[0002]All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by referenceBACKGROUND OF THE INVENTION[0003]The invention relates to systems, devices, and tools, and the use of such systems, devices and tools for monitoring blood glucose levels in a person having diabetes. More specifically, the invention relates to systems, devices, and tools and the use of such systems, devices and tools for monitoring blood glucose level continuously, or substantially continuously.[0004]Diabetes is a chronic, life-threatening disease ...

AI Technical Summary

Problems solved by technology

Diabetes is a chronic, life-threatening disease for which there is no known cure.

Diabetes is usually irreversible, and can lead to a variety of severe health complications, including coronary artery disease, peripheral vascular disease, blindness and stroke.

For a person with diabetes, the insulin response does not function properly (either due to inadequate levels of insulin production or insulin resistance), resulting in blood glucose levels below 80 mg / dL during fasting and well above 140 mg / dL after a meal.

Currently, persons suffering from diabetes have limited options for treatment, including taking insulin orally or by injection.

In some instances, controlling weight and diet can impact the amount of insulin required, particularly for non-insulin dependent diabetics.

Failure to manage the disease properly has dire consequences for diabetics.

These systems rely on lancing and manipulation of the fingers or alternate blood draw sites, which can be extremely painful and inconvenient, particularly for children.

These sensors are painful during insertion and usually require the assistance of a health care professional.

Subcutaneously implanted sensors also frequently lead to infection and immune response complications.

Another major drawback of currently available continuous monitoring devices is that they require frequent, often daily, calibration using blood glucose results that must be obtained from painful finger-sticks using traditional meters and test strips.

This calibration, and re-calibration, is required to maintain sensor accuracy and sensitivity, but it can be cumbersome as well as painful.

Temperature and perspiration are also known to affect its accuracy.

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